A Single-Blinded Randomized Controlled Trial Comparing Modified Brostrӧm Procedure With and Without Diagnostic Arthroscopy for Treatment of Lateral Ankle Instability
| Registry | NCT02470338 |
|---|---|
| Status | Withdrawn - Withdrawn as researcher left |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Sponsor | Edna Rath (Fed) |
| Conditions | Lateral Ankle Instability |
| Interventions | MBP plus arthroscopy (Group A), MBP alone (Group B) (Procedure) |
| Dates | start 2015-06-01, primary completion 2018-04-01 (estimated), completion 2018-06-01 (estimated), first posted 2015-06-12, last updated 2025-09-25 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Lateral Ankle Instability All trials of MBP plus arthroscopy (Group A) All trials of MBP alone (Group B)
This study is to show that the investigators believe the Modified Brostrӧm Procedure (MBP) can be completed without a routine ankle arthroscopy. Routine ankle arthroscopy, if determined not to be necessary in all cases, is a waste of resources in terms of operating room, surgeon, and staff time as well causing an increase in hospital financial expenses. Most importantly, this procedure is morbid. Ankle arthroscopy forces a patient's foot into distraction for up to one hour, exposes the patient to potentially longer anesthesia exposure that is unnecessary, increases infectious risks, and requires exposure at the portal sites near superficial nerves.
The purpose of this investigation is to determine if ankle arthroscopy is necessary in the treatment of routine ankle instability without evidence of intra-articular pathology on MRI. Our study population will include those individuals whose ankle MRI is inconclusive or negative for intra-articular pathologies, and intra-articular ankle pain is not a predominant presenting symptom. Although it is our current practice at WBAMC not to conduct an ankle arthroscopy on this group of patients, there is a debate in the literature on whether the arthroscopy should be conducted. Thus, the purpose of this study is to examine the MBP with and without ankle arthroscopy.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| MBP plus ankle arthroscopy (Group A) | Active comparator | Procedure: MBP plus arthroscopy (Group A) | Group A will receive a diagnostic ankle arthroscopy followed by the Modified Brostrӧm Procedure (MBP). In the ankle arthroscopy, multiple pictures are taken inside of the joint to note possible pathologic processes (for example - osteochondral lesions of the talus). Ankle arthroscopy involves one incision in the middle of the ankle anteriomedial (middle) incision and one incision on the outside of the ankle. Each incision (a small cut in the skin) is roughly 5mm in length (which is about 0.2 inches). After the incision is made, the participant will receive a diagnostic ankle arthroscopy.If the surgeon detects an abnormality inside the joint, he will operate on the abnormality with the arthroscope according to the generally accepted principles for treating the abnormality. |
| MBP alone (Group B) | Sham comparator | Procedure: MBP alone (Group B) | Group B will receive sham skin incisions on the ankle a Modified Brostrӧm Procedure (MBP) alone (that is, there will be no diagnostic ankle arthroscopy) followed by the Modified Brostrӧm Procedure (MBP). If a participant is assigned to Group B, the participant will receive two small superficial skin incisions at the sites where the investigators would normally insert instruments for the ankle arthroscopy. As with Group A, there will be one anteriomedial (middle) incision on the middle of the ankle and one anteriolateral (side) incision to on the outside of the ankle. Each incision will be roughly 5mm in length and 5 mm in depth, but will not violate subcutaneous tissue. The width of these incisions will be the width of the blade, at 1mm. However, unlike Group A, the participants in Group B will not have any instruments inserted into their ankle and will not have any operation to repair or remove damaged tissue. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: 1. Able to independently consent for surgery 2. Able to demonstrate an understanding of study procedures 3. Adult patient 18 years of age or older 4. All active duty soldiers, Veterans, dependents 5. Ability to comply with study procedures for the entire length of the study 6. Presence of lateral ankle instability meeting operative criteria listed in 6.2.1 with documented failed conservative measures such as: physical therapy, ankle braces, and rest Exclusion Criteria: 1. Unable to obtain medical clearance for surgery 2. Recent (1 month) febrile illness that precludes or delays participation 3. History of or suspected of drug/alcohol abuse, as these patients may not be compliant with physical therapy. All patients are required to be immobilized for 6 weeks after surgery 4. Pregnant women, this is an elective procedure and a MBP or ankle arthroscopy is not typically offered to pregnant women. Screening for pregnancy is done as part of standard of care
| Facility | City | Country | Status |
|---|---|---|---|
| William Beaumont Army Medical Center | El Paso, Texas | United States |